FDA.reportPublic FDA data

System, mcompass®, Anorectal Manometry

Primary DI
00851607003457
Brand
System, mcompass®, Anorectal Manometry
Company
MEDSPIRA, LLC
Model
RMD-201
Device description
System, mcompass®, Anorectal Manometry
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851607003454PackageGS15In Commercial Distribution
00851607003457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085160700345410851607003454
00851607003457008516070034578516070034570851607003457

GMDN Terms#

Term, Definition table
TermDefinition
Manometric gastrointestinal motility analysis systemAn assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Product should be kept dry

Contacts#

Phone, Email table
PhoneEmail
612-789-0013info@medspira.com

Regulatory Flags#

DUNS number
962187964
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851607003501mcompass Anorectal Balloon Expulsion CatheterRMD-003-001RMD-003-0012025-12-30
00851607003006QuikLinq FOB Adapter RMD-210-0202025-03-10
10851607003003QuikLinq FOB Adapter RMD-210-0202025-03-10
008516070035325-Pack, Luer-Locking, 100cc SyringeRMD-010-0172025-03-03
108516070035395-Pack, Luer-Locking, 100cc SyringeRMD-010-0172025-03-03
008516070035185-Pack, 100 cc Syringe, Luer-lockingRMD-010-0162024-12-20
108516070035155-Pack, 100 cc Syringe, Luer-lockingRMD-010-0162024-12-20
00851607003389System Accessory KitRMD-010-0112024-11-30
10851607003386System Accessory KitRMD-010-0112024-11-30
00851607003525Battery, Tablet PCRMD-010-0092024-11-30
00851607003235LED MonitorRMD-002-MON2021-07-01
00851607003341Single Patient Kit, mcompass, Anorectal Manometry 2-channelRMD-002-0112023-10-06
00851607003372Medspira Tablet PC with Power SupplyRMD-010-0102023-10-06
00851607003396mcompass Anorectal Manometry SystemRMD-001U2023-10-06
00851607003419Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-packRMD-202-0072023-10-06
00851607003426Catheter, mcompass®, Biofeedback, 2-channel, 5-packRMD-202-0042023-10-06
00851607003433Extension Tube, mcompass® Catheter, 5-packRMD-202-0062023-10-06
00851607003440Extension Tube, mcompass® Catheter, 5-packRMD-201-0012023-10-06
00851607003464System, mcompass®, Anorectal Manometry RMD-201U2023-10-06
00851607003471System, mcompass®, Biofeedback TherapyRMD-2022023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00678467508409Mui ScientificH & A Mui Enterprises IncKLA2025-11-17
00678467508225Mui ScientificH & A Mui Enterprises IncKLA2025-04-07
00851607003006QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
10851607003003QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
00627825014830SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
00627825014823SOLAR Anorectal Manometry ChargerLaborie Medical Technologies Corp.KLA2025-03-06
10627825014837SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
008516070035325-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
108516070035395-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
00678467508201Mui ScientificH & A Mui Enterprises IncKLA2025-02-20
68051887046715THD Procto Software SystemTHD SPAKLA2025-02-20
B960RED201REDNeuraxis, Inc.KLA2025-01-09
008516070035185-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
108516070035155-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
00851607003389System Accessory KitMEDSPIRA, LLCKLA2024-11-30
10851607003386System Accessory KitMEDSPIRA, LLCKLA2024-11-30
00851607003525Battery, Tablet PCMEDSPIRA, LLCKLA2024-11-30
00678467508157Mui ScientificH & A Mui Enterprises IncKLA2024-10-11
00678467508140Mui ScientificH & A Mui Enterprises IncKLA2024-07-03
00678467508133Mui ScientificH & A Mui Enterprises IncKLA2024-06-21
00678467508089Mui ScientificH & A Mui Enterprises IncKLA2024-04-16
00678467508096Mui ScientificH & A Mui Enterprises IncKLA2024-04-16
00678467508072Mui ScientificH & A Mui Enterprises IncKLA2024-03-21
68051887043295THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043301THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043318THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043325THD Procto Software SystemTHD SPAKLA2023-12-14
00851607003341Single Patient Kit, mcompass, Anorectal Manometry 2-channelMEDSPIRA, LLCKLA2023-10-06
00851607003372Medspira Tablet PC with Power SupplyMEDSPIRA, LLCKLA2023-10-06
00851607003396mcompass Anorectal Manometry SystemMEDSPIRA, LLCKLA2023-10-06